Characteristics and Prescribing Patterns of Clinicians Waivered to Prescribe Buprenorphine for Opioid Use Disorder Before and After Release of New Practice Guidelines

Key Points Question In what way do the characteristics of clinicians who received Drug Addiction Treatment Act (DATA) waivers under the 2021 education-exempted US Department of Health and Human Services buprenorphine practice guidelines differ from those who obtained their DATA waiver through traditional waiver approval pathways? Findings In this survey study of 2736 clinicians, those waivered under the education-exempted guidelines were less likely than traditionally waivered clinicians to prescribe buprenorphine and more likely to practice in emergency or urgent care settings. The survey identified multiple barriers to buprenorphine prescribing across waiver approval types. Meaning The findings suggest that multipronged efforts may be needed to focus on addressing clinician-, patient-, and systems-level barriers to prescribing buprenorphine.


Introduction
Buprenorphine, a highly effective treatment for opioid use disorder (OUD), is the most accessible form of medication for OUD (MOUD) in the US 1,2 but remains substantially underused. 2, 3 Historically, only clinicians who obtained a Drug Addiction Treatment Act (DATA) waiver could prescribe buprenorphine for OUD treatment. 2,4 Most eligible clinicians did not obtain such a waiver, and research identified educational training requirements as 1 reason for this lack of uptake. [5][6][7] With passage of the Consolidated Appropriations Act of 2023, the US Congress legislatively removed the DATA waiver to prescribe buprenorphine for OUD. 8 Although this change has the potential to substantially increase access to buprenorphine treatment, prior research has shown that there are multiple clinician-, patient-, and systems-level barriers to care independent of the DATA waiver that may continue to limit buprenorphine prescribing. 3,5,9,10 Assessing the outcomes of regulatory action by the US Department of Health and Human Services (HHS) in April 2021 aimed at removing the educational training requirement prior to obtaining a DATA waiver may provide important insight into how the recent legislative change of fully removing the DATA waiver might change clinical practice with respect to buprenorphine prescribing and what barriers to prescribing remain even after removal of the educational requirement. On April 27, 2021, the HHS released its Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, 4 which provides an additional pathway to obtain a DATA waiver by exempting eligible clinicians from the federal education requirements needed to obtain a DATA waiver to treat up to 30 concurrent patients with buprenorphine. Clinicians, including those interested in treating more than 30 patients concurrently, could still obtain a traditional DATA waiver after release of the practice guidelines.
A recent study found that the HHS practice guidelines were associated with an acceleration in the growth of clinicians obtaining a 30-patient-limit DATA waiver, 11 consistent with other research that showed increases in numbers of DATA-waivered clinicians after release of the practice guidelines. 12,13 The analysis also found that this increase in waivered clinicians did not translate into an acceleration in patients filling buprenorphine prescriptions above historical trends. 11 Importantly, these studies [11][12][13] could not examine how clinicians seeking a waiver under the education-exempted practice guidelines were similar to or different from those seeking a traditional waiver before the release of the practice guidelines or those obtaining a traditional waiver after the release of the practice guidelines, a group completing educational requirements despite no longer being required.
Furthermore, prior studies have not examined buprenorphine prescribing practices or barriers to prescribing MOUD and how these compare with traditionally waivered clinicians. To address this research gap, we conducted a survey to compare traditionally waivered clinicians before or concurrent with release of the education-exempted practice guidelines and those waivered under the practice guidelines in order to gain actionable insights as policy makers and the clinical community begin implementation of buprenorphine treatment without the need for the DATA waiver.

Study Sample and Data Collection
We conducted a cross-sectional survey study of 3 subpopulations of clinicians: (1) clinicians obtaining a traditional 30-patient-limit DATA waiver in the 12 months prior to the release of the HHS practice guidelines (April 2020 to April 2021); (2) clinicians receiving a traditional 30-patient-limit DATA waiver during the 6 months following the release of the guidelines (June 2021 to November 2021); and (3) clinicians who received a DATA waiver under the guidelines during the same 6-month period (June 2021 to November 2021). Data on clinicians with a DATA waiver were from the Drug Enforcement Administration's controlled substances registration database and based on the date the clinician received their initial 30-patient waiver. Initial emails with an embedded survey link were sent to each eligible clinician using REDCap 14 (Vanderbilt University) on February 1, 2022, with reminder emails 1.5 and 3 weeks later; the survey closed after 4 weeks on March 1, 2022. The Centers for Disease Control and Prevention determined this investigation to be public health surveillance and exempt from institutional review board review by regulation. 15 The email invitation to participate in the survey indicated that by participating, the respondent provides informed consent. This study followed the American Association for Public Opinion Research (AAPOR) recommendations for conducting surveys, including method of survey delivery, survey design and testing, and reporting results. 16

Survey Design
The 45-question survey instrument (eTable 1 in Supplement 1) was based on prior surveys examining buprenorphine prescribing and barriers to prescribing 9,10 and expert review. The survey included questions in 3 domains: (1) clinician demographic and practice characteristics, (2) buprenorphine prescribing practices and barriers to prescribing, and (3) challenges faced and strategies used to treat patients with OUD. Survey respondents self-reported data on demographic characteristics from provided categories, including gender identity (female; male; nonbinary/genderqueer/gender nonconforming/neither exclusively male or female; and other), race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, and White), and ethnicity (Hispanic or Latino and not Hispanic or Latino). These variables were of interest to identify potential demographic disparities by clinician type and waiver approval type, an area that has been underexplored in previous research.

Statistical Analysis
We report descriptive statistics for clinician demographic and practice characteristics overall and by the 3 independent groups based on DATA waiver type (traditional vs HHS practice guidelines) and timing of receipt of their waiver as follows: (1) traditional waiver before HHS practice guidelines (hereafter prior DATA waiver), (2) traditional waiver after HHS practice guidelines (hereafter concurrent DATA waiver), and (3) waiver under education-exempted HHS practice guidelines (hereafter practice guidelines). We calculated frequencies and percentages for questions related to buprenorphine prescribing practices, barriers to remote prescribing, challenges faced, and strategies used to treat patients with OUD among clinicians who reported prescribing buprenorphine in the past 6 months or since obtaining a waiver under the practice guidelines.
We conducted all analyses with Stata, version 15.1 (StataCorp LLC) statistical software using χ 2 tests and z-tests to assess for statistically significant differences among groups based on waiver type. Two-tailed P < .05 was considered statistically significant.

Reasons for Not Obtaining a Traditional DATA Waiver
Among practice guidelines clinicians, 500 (60.9%) indicated that requirements for educational training for the traditional DATA waiver was a reason for not previously obtaining a traditional DATA waiver (Figure 1)

Reasons for Not Prescribing Buprenorphine Since Obtaining DATA Waiver
Among respondents who had not prescribed buprenorphine since obtaining their DATA waiver, reasons for not prescribing varied (Figure 2)  for an individual characteristic may not sum to the total number of respondents for each waiver approval type category.
b Among clinicians who reported prescribing in the past 6 months for those obtaining a traditional DATA waiver or since obtaining a waiver under the practice guidelines.

Number of Patients Prescribed Buprenorphine
Most clinicians who had prescribed buprenorphine in the past 6 months prescribed to 1 to 4 patients in an average month and in the past month, regardless of waiver approval type (Figure 3)

Strategies to Monitor and Engage Patients Prescribed Buprenorphine
Among clinicians prescribing buprenorphine in the past 6 months, strategies to monitor and engage patients prescribed buprenorphine varied by waiver group (Figure 4)

Discussion
To our knowledge, this survey study is the first to assess the similarities and differences of clinicians who obtained a DATA waiver under the education-exempted HHS buprenorphine practice guidelines released in April 2021 compared with clinicians who received a traditional DATA waiver prior to and after release of the practice guidelines. These findings are particularly salient given the recent federal legislative changes included in the fiscal year 2023 Congressional Omnibus Appropriation law that a Significant difference between practice guidelines and prior DATA waiver. b Significant difference between prior DATA waiver and concurrent DATA waiver. c Significant difference between practice guidelines and concurrent DATA waiver. eliminates the requirement to obtain a DATA waiver in order to prescribe buprenorphine for OUD treatment. 13 Practice guidelines clinicians were similarly exempted from DATA waiver educational requirements; therefore, the characteristics of these clinicians and their practice patterns may provide some insight into how the OUD treatment landscape is expected to evolve after DATA waiver elimination and may inform the need for complementary policy and education initiatives to expand access to MOUD.

JAMA Health Forum | Original Investigation
Our findings suggest that the composition of clinicians opting into buprenorphine-based treatment may change as the regulatory requirements for prescribing buprenorphine evolve. For example, practice guidelines clinicians were more likely to be physicians, practice in ED or urgent care settings, and practice in urban areas. Our finding that more physicians as well as clinicians practicing in urban settings is consistent with prior research that examined trends in DATA-waivered clinicians during the COVID-19 pandemic and after release of the HHS practice guidelines in 2021. 12 As the regulatory paradigm for buprenorphine prescribing evolves with the elimination of the DATA waiver, it will be important to track the types of clinicians prescribing buprenorphine, identify untapped pools of clinicians not engaging in prescribing, and tailor training and technical assistance accordingly.
Practice guidelines clinicians were less likely to incorporate other interventions and monitoring strategies in caring for patients with OUD compared with both traditional DATA waiver groups. Some of these differences were related to the larger percentage of ED and urgent care clinicians in the practice guidelines group (39.9%) compared with 17.0% and 12.5% in the prior and concurrent DATA waiver groups, respectively. In these settings, transient clinician-patient relationships make additional interventions, such as individual and group counseling, and monitoring strategies, including pill and film counts and conducting urine drug testing, less common compared with officebased settings. As restrictions on buprenorphine prescribing are further removed, it will be important to monitor practice patterns, quality of care, and treatment outcomes to assess intended and unintended outcomes of policy changes.
More immediately, regardless of waiver type, only approximately one-half of clinicians reported prescribing naloxone for overdose prevention to this high-risk population, a particularly concerning finding. The Centers for Disease Control and Prevention, 17  Our findings confirm that multiple barriers to wider adoption of buprenorphine treatment for OUD exist beyond removal of training requirements. Consistent with prior research, 3,5,9,10 access to In-person urine drug testing a,b Group remote telehealth counseling with video other services, including psychosocial services, and access to specialists, such as addiction medicine and psychiatric clinicians, remain as barriers to buprenorphine prescribing, even among clinicians who took the initial step to obtain a waiver. In addition, although practice guidelines clinicians responding to the survey reported less patient demand for buprenorphine than did traditionally waivered clinicians, all 3 groups noted lack of patient demand as the most common reason for not prescribing buprenorphine since obtaining a waiver. Furthermore, the fact that the majority of clinicians surveyed, regardless of waiver type, reported prescribing to 1 to 4 patients in an average month mirrors prior research showing that most DATA-waivered clinicians prescribe far below their patient limits. 20 This underused treatment capacity may reflect challenges with patient engagement or interest, lack of screening for and identification of patients with OUD in clinical settings, and organizational and policy barriers that hinder clinicians' efforts to incorporate OUD treatment into their practice.
Taken together, this study highlights the ongoing challenges with providing and engaging in buprenorphine treatment, even when an often-invoked barrier to prescribing, the educational requirement prior to obtaining a DATA waiver, is removed. Taking stock of these findings is paramount as the medical community and policy makers begin to implement actions in the context of DATA waiver elimination. It is hoped that these substantial policy changes will revolutionize the delivery of buprenorphine treatment. Our findings, coupled with recent research of waiver trends and buprenorphine prescribing after implementation of the education-exempted practice guidelines, 11 suggest that removal of this barrier to entry for clinicians may not on its own necessarily translate to large-scale increases in buprenorphine prescribing against the backdrop of multiple clinician and patient challenges.
To fully optimize the outcomes of the DATA waiver elimination law, it will be critical to focus on clinician barriers, systems-level improvements, and payment policy changes that support models of care that integrate behavioral health services; incentivize MOUD; expand the substance use disorder workforce; counter clinician, patient, and institutional stigma; and provide training and technical assistance to support a broad range of clinicians in delivering care to patients with OUD and other substance use disorders. At the same time, policies, programs, and practices that holistically support patients to link to and engage in care are important.
This exploratory survey highlights several important topics for further investigation. First, the finding that clinicians practicing in ED or urgent care settings are overrepresented in the practice guidelines group suggests that removing training and administrative barriers to prescribing MOUD may be particularly important in this setting. Understanding the reasons for these differential increases and finding ways to enhance their positive association with patient outcomes following emergency medical care is a key next step. Second, understanding outcomes of patients treated under the practice guidelines is essential, as it may lend insight into how patient outcomes are expected to change after DATA waiver removal. Third, multiple surveys have found lack of patient demand as a key clinician-reported reason for not prescribing buprenorphine after obtaining a waiver. 9,10 Future research should explore contributors to patient demand and patient-level drivers and disincentives of engagement in care.

Limitations
This study has several limitations. First, although our response sample was large and incorporated variation with regard to demographic and clinical characteristics, the response rate was 19.5%, with 60.5% of respondents providing sufficient information to be included in this specific analysis; thus, findings may be subject to nonresponse bias. Second, the survey asked about a range of clinician barriers and strategies to treating patients; however, other barriers or strategies not assessed may exist. Third, while our survey instrument was largely drawn from prior surveys and expert review, some respondents might have misinterpreted some survey questions.

Conclusions
In this survey study of clinicians recently receiving DATA waivers, we found that the educationexempted HHS practice guidelines brought in new clinicians, particularly physicians and clinicians practicing in ED and urgent care settings, although overall prescribing rates among this group were generally lower than among clinicians who obtained a traditional DATA waiver prior to or after release of the practice guidelines. Across all waiver approval types, we identified multiple barriers to buprenorphine prescribing and suboptimal use of strategies to manage risk among patients with OUD. As the medical community and policy makers begin to respond to legislation that has removed the DATA waiver, our findings suggest that it will be important that future efforts also focus on addressing the multiple challenges that constrain buprenorphine prescribing and engagement in care.